FDA Reviews Depemokimab for Asthma

The proposed indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

The Prescription Drug User Fee Act (PDUFA) date is 16 December 2025.

Depemokimab, a monoclonal antibody that targets IL-5, is the first ultra-long-acting biologic to be evaluated in phase III trials and be accepted for regulatory review for use in these conditions.Depemokimab's extended half-life, high-binding affinity and potency, support six month (26 week) dosing regimens based on results from the SWIFT and ANCHOR trials.. In patients with asthma with type 2 inflammation and patients with CRSwNP, these trials met their primary endpoints, showing that depemokimab could offer sustained inhibition of a key driver of their disease, and help achieve key clinical outcomes with a dosing schedule of just two injections per year. As demonstrated in studies of other diseases, longer intervals between doses have been shown to overcome barriers to optimal care, such as patient adherence.

Asthma affects more than 260 million people globally, many of whom continue to experience symptoms and exacerbations despite treatment with high-dose inhaled corticosteroids plus a second controller (and/or systemic corticosteroids). Asthma presents a significant financial burden to patients as exacerbations place a resource burden on healthcare systems due to emergency department visits and hospitalisations.